Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
epirubicin hydrochloride, Quantity: 2 mg/mL
Fresenius Kabi Australia Pty Ltd
epirubicin hydrochloride
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections
Intravesical, Intravenous
1
(S4) Prescription Only Medicine
Epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases and is indicated for the treatment of:,? breast cancer,? gastric cancer,? ovarian cancer,? small cell lung cancer,? lymphoma (non-Hodgkin?s lymphoma),? advanced/metastatic soft tissue sarcoma,? superficial bladder cancer (Tis; Ta).,In bladder cancer, epirubicin hydrochloride is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (Grade 2 and 3).
Visual Identification: Clear red coloured solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2011-11-21
CMI for Epirubicin Kabi November, 2011 Filename: EpiCMI011111 Page 1 of 3 EPIRUBICIN KABI INJECTION Epirubicin hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Epirubicin Kabi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Epirubicin Kabi against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT EPIRUBICIN KABI IS USED FOR Epirubicin Kabi is used in the treatment of various types of cancer. It may be used alone or with other medicines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY EPIRUBICIN KABI HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. Epirubicin Kabi is only available with a doctor's prescription. It is not addictive. BEFORE YOU ARE GIVEN EPIRUBICIN KABI _WHEN YOU MUST NOT BE GIVEN IT _ DO NOT USE EPIRUBICIN KABI IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO EPIRUBICIN (THE ACTIVE INGREDIENT IN EPIRUBICIN KABI), OTHER MEDICINES TO TREAT CANCER OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT USE THE MEDICINE FOR INJECTION INTO A VEIN IF YOU HAVE: a low number of red blood cells, white blood cells or platelets in your blood sore, red mouth from previous treatment or radiation therapy an infection severe liver problems heart problems or have ever had heart problems already received the highest dose allowed for medicines such as mitozantrone, mitomycin C, doxorubicin or daunorubicin DO NOT USE THE MEDICINE FOR INJECTION INTO THE BLADDER IF YOU HAVE: cancer that has gone into the bladder wall kidn Baca dokumen lengkap
Filename: EpiPI011111 Page 1 of 14 PRODUCT INFORMATION NAME OF MEDICINE Epirubicin Kabi Solution for Injection DESCRIPTION Structurally, epirubicin hydrochloride differs from doxorubicin hydrochloride only in the orientation of the hydroxyl group at the 4 position on the aminoglycoside ring. The chemical name of epirubicin hydrochloride is (8S, 10S)-10-(3-amino-2,3,6-trideoxy-α-L- arabinohexopyranosyloxy)-8-glycolloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1 methoxynaphthacene-5,12-dione hydrochloride. The structural formula is: Empirical formula: C 27 H 29 NO 11 ·HCl Molecular weight: 579.99 CAS number: 56390-09-1 Epirubicin hydrochloride is a red-orange, almost odourless, hygroscopic powder, sparingly soluble in water and dilute alcohol. Epirubicin hydrochloride is available as a ready-to-use solution (Epirubicin Kabi). Epirubicin Kabi is a clear red coloured solution of epirubicin hydrochloride and sodium chloride in Water for Injections. Hydrochloric acid is added as necessary to adjust the pH. The solution is available as a 2 mg/mL solution in 10 mg/5 mL, 50 mg/25 mL and 200 mg/100 mL presentations. PHARMACOLOGY The mechanism of action of epirubicin hydrochloride has not been fully elucidated but is probably related to its ability to bind DNA. Cell culture studies have shown cell penetration, localisation in the nucleus and inhibition of nucleic acid synthesis and mitosis. Epirubicin hydrochloride has proved to be active on the following experimental tumours: L 1210 ascites and P388 leukaemias, sarcoma SA 180 (solid and ascitic forms), melanoma B 16, mammary carcinoma, Lewis lung carcinoma and colon carcinoma 38. The specificity of epirubicin hydrochloride toxicity appears to be related primarily to proliferative activity of normal tissue. Thus, bone marrow, gastrointestinal tract, lymphoid Filename: EpiPI011111 Page 2 of 14 organs and the gonads are the main normal tissues damaged. Degenerative or functional alterations in liver and kidneys were also seen in animals dosed with epirubicin hydrochloride. Lik Baca dokumen lengkap